Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD) (REVASK)

Myocardial infarction and chronic coronary heart disease (cCHD) are the most frequent causes of death in Germany. Treatment options include widening of the narrowed / blocked coronary vessel via catheter and stent or bypass surgery in which the narrowed vessel sites are bridged. The "German National Disease Management Guideline on cCHD" helps doctors to decide which treatment is most appropriate for the severity of vascular damage and possible concomitant diseases of the patient. Nevertheless, there are other factors determining treatment decision. For example, the equipment or preferences of the hospital or department in which patients are admitted, play a role in the decision.

The aim of the REVASK project is to investigate whether and to what extent the collaboration of cardiology and heart surgery specialists in so-called "heart teams" influences the decision on therapy.

For this purpose, doctors and patients will be interviewed about how the treatment decision was made and how satisfied both sides are with the outcome of the treatment and the decision. In addition, claims data from several German health insurance companies (Techniker, BARMER, Betriebs- und Innungskrankenkassen) will be analyzed. Treatment data, which is documented as usual by the treating medical staff and passed on to the health insurance companies for accounting purposes, is used. Furthermore, treatment data recorded in the registers of the professional societies is analyzed.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease

• Study Type: Observational
• Enrollment (Actual): 385

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany
    • Pädagogische Hochschule Freiburg Public Health & Health Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatient cardiology practices, hospitals with a cardiology department and hospitals with a cardiology and heart surgery department (n=20) in Germany

Description

Inclusion Criteria:

• with chronic coronary heart disease
• and 2- or 3-vessel or main-vessel disease
• who are being treated at one of the recruitment sites
• with a promptly planned intervention for myocardial revascularization
• who are insured with pre-specified German health insurance companies (BARMER or TK)

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Patients with CHD; outpatient cardiology practices, hospitals with a cardiology department and hospitals with a cardiology and heart surgery department (n=20) in Germany Patients with chronic coronary heart disease and 2- or 3-vessel or main-vessel disease who are being treated at one of the recruitment sites with a promptly planned intervention for myocardial revascularization who are insured with pre-specified German health insurance companies (BARMER or TK) Patients will receive questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Guideline compliance	Guidelines-compliant therapy in patients with chronic CHD (2- or 3-vessel or main vessel disease) according to German National Disease Management Guideline on chronic coronary heart disease	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart teams	Frequency and quality of heart teams	2 years
Patient participation	extent of patient participation in the decision making process	2 years
Decision making process	importance of clinical parameters in the decision-making process (e.g. syntax scores, iFR, FFR)	2 years

Collaborators and Investigators

• Sponsor: InGef - Institute for Applied Health Research Berlin GmbH
• Collaborators: BARMER; Stiftung Institut fuer Herzinfarktforschung; Universitätsklinikum Köln; Techniker Krankenkasse; University of Education Freiburg; Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG)

Publications and helpful links

Helpful Links

• The official website of the REVASK project

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: cardiology; decision making; myocardial revascularization; heart surgery; Chronic coronary heart disease; heart team
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 01VSF18010; DRKS00022175 (Registry Identifier: German clinical trials register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Research data can be shared with persons or institutions with a legitimate scientific interest after consultation in the consortium and only in pseudonymised form and within the scope of the EU-GDPR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No